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Product NDC Code | 73517-381 | ||||||||
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Drug Name | Biossance squalane moisturizer spf30 |
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Type | Brand | ||||||||
Pharm Class | Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE] |
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Active Ingredients |
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Route | TOPICAL | ||||||||
Dosage Form | LOTION | ||||||||
Application Number | M020 | ||||||||
Labeler Name | Amyris, Inc | ||||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Zinc Oxide 14% Purpose Sunscreen
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions Apply generously 15 minutes before sun exposure reapply at least every 2 hours Sun Protection Measures Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularyly use a sunscreen with a Broad Spectrum value of SPF 15 or higher and other sun protection measures including Limit time in the sun, especially from 10 a.m.- 2 p.m. wear long-sleeved shiirts, pants, hats and sunglasses use a water-resistant sunscreen if swimming or sweating children under 6 months of age:ask a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water, Caprylic/Capric Triglyceride, Zinc Oxide, Glycerin, Squalane, Cetearyl Alcohol, Methyl Dihydroabietate, Dipropylene Glycol, Sorbitan Olivate, Cetyl Palmitate, Coco Glucoside, Phenoxyethanol, Sodium Palmitoyl Proline, Ethyl Ferulate, Isostearic Acid, Lecithin, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Caprylyl/Capryl Glucosides, Butylene Glycol, Nymphaea Alba Flower Extract, Ethylhexylglycerin, Acacia Senegal Gum, Xanthan Gum, Sodium Gluconate, Glucose.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses Helps prevent sunburn if used as directed with other sun protection measures(see directions) , decreases the risk of skkin cancer and early signs of aging caused by the sun.
Purpose
Information about the drug product’s indications for use.Purpose Sunscreen
Spl product data elements
Usually a list of ingredients in a drug product.Biossance Squalane Moisturizer SPF30 Zinc Oxide WATER MEDIUM-CHAIN TRIGLYCERIDES GLYCERIN SQUALANE CETOSTEARYL ALCOHOL METHYL DIHYDROABIETATE DIPROPYLENE GLYCOL SORBITAN OLIVATE CETYL PALMITATE COCO GLUCOSIDE PHENOXYETHANOL SODIUM PALMITOYL PROLINE ETHYL FERULATE ISOSTEARIC ACID LECITHIN, SOYBEAN POLYGLYCERYL-3 RICINOLEATE POLYHYDROXYSTEARIC ACID (2300 MW) CAPRYLYL/CAPRYL OLIGOGLUCOSIDE BUTYLENE GLYCOL NYMPHAEA ALBA FLOWER ETHYLHEXYLGLYCERIN ACACIA SENEGAL WHOLE XANTHAN GUM SODIUM GLUCONATE ANHYDROUS DEXTROSE ZINC OXIDE ZINC CATION
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Figure
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use on damaged of broken skin When using this product keep out of eyes. Rinse with water to remove Stop use and ask a doctor if rash occurs Keep out of reach of children If product is swallowed, get medical help or contact a Poison Control Center right away.
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children If product is swallowed, get medical help or contact a Poison Control Center right away.
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if rash occurs Keep out of reach of children If product is swallowed, get medical help or contact a Poison Control Center right away.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product keep out of eyes. Rinse with water to remove Stop use and ask a doctor if rash occurs Keep out of reach of children If product is swallowed, get medical help or contact a Poison Control Center right away.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings For external use only
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API